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Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today announced an update on the COSIRA-II Clinical Trial ("Trial") status. COSIRA-II is the U.S. Investigational Device Exemption ("IDE") pivotal clinical trial the Company is executing for the Neovasc Reducer™ ("Reducer") towards an approval decision for the device in the United States. The Trial will randomize approximately 380 patients at up to 50 sites in North America. To date, 55 patients have been enrolled at 17 active sites. The Company has undertaken several initiatives to further accelerate enrollment in the Trial, including machine learning technology, expanding the field clinical team, and initiating enrollments in Canada. Neovasc aims to complete randomization in the first half of 2024.
Machine Learning to Accelerate Patient Recruitment
To accelerate recruitment of patients into the Trial, Neovasc is leveraging predictive machine learning technology from Komodo Health, to identify and engage healthcare practitioners ("HCP") with screening-eligible patients at exactly the right moment in their care journey. Komodo's clinical-alerting solution, Pulse, is built on the de-identified, longitudinal healthcare journeys of more than 330 million patients for real-time visibility into specific, complex patient populations. Komodo is deploying an algorithm into production that pinpoints HCPs who treat patients with refractory angina based on their use of a specific treatment and prescription history, empowering Neovasc's clinical team to drive more efficient recruitment and accelerate Trial completion. Pharmaceutical companies have used the technology to accelerate clinical trial enrollment while maintaining Health Insurance Portability and Accountability Act ("HIPAA") compliance.
Expansion of Clinical Trial Field Execution Team
The Company continues to expand its Clinical Affairs team with the recent hire of a Site Engagement Manager. The new role is designed to accelerate enrollments in the Trial by partnering with key personnel at COSIRA–II Trial sites and driving patient identification with the sites.
"COSIRA-II is a landmark clinical trial that has the potential to change clinical practice. Refractory angina places a huge burden on patients, physicians and the healthcare system, and we're positioned to be at the forefront of developing a therapy to alleviate the challenges of the condition," commented Sarah Gallagher, Neovasc Vice President of Clinical Affairs. "I look forward to building on the momentum we have created in the Trial and to further accelerate our enrollments."
Investigational Testing Authorization ("ITA") Approval from Health Canada
The Trial has received ITA approval including three initial sites approved by Health Canada. A limited number of investigational sites in Canada will join in the COSIRA-II Trial. An additional five sites will be added with up to 75 Canadian patients approved. While a majority of patients will be United States patients, the Canadian site additions will allow for Canadian patients to participate in the study and the Company expects the Canadian approval to accelerate enrollment and randomizations.
Reimbursement from the Centers for Medicare and Medicaid Services
As the Company previously announced, the Reducer implant procedure now has adequate coding, coverage and payment in the United States from the Centers for Medicare and Medicaid Services, for both the randomized arms of the Trial and the recently approved single arm. The single arm will enroll specific subsets of patients including those with angina and non-obstructive coronary artery disease.
About Reducer
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure.
While the Reducer is not approved for commercial use in the United States, it is being studied in the COSIRA-II Clinical Trial, and the FDA granted Breakthrough Device designation to the Reducer in October 2018. Breakthrough designation is granted by the FDA in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.
Posted In: NVCN
